K-Systems K59700
GUDID 05060554120048
Assisted Reproduction Accessories
RESEARCH INSTRUMENTS LIMITED
Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator Assisted reproduction heater/incubator| Primary Device ID | 05060554120048 |
| NIH Device Record Key | ad65c35b-d9aa-4e1b-976b-bd4641459b9b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-Systems |
| Version Model Number | G210 InviCell Standard US Incubator |
| Catalog Number | K59700 |
| Company DUNS | 536139413 |
| Company Name | RESEARCH INSTRUMENTS LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com | |
| Phone | 4546790202 |
| origio@origio.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060554120048 [Primary] |
FDA Product Code
| PUB | Accessory, Assisted Reproduction, Exempt |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-01-31 |
On-Brand Devices [K-Systems]
| 05060554120307 | Assisted Reproduction Accessories |
| 05060554120291 | Assisted Reproduction Accessories |
| 05060554120048 | Assisted Reproduction Accessories |
| 05060554120017 | Assisted Reproduction Accessories |
Trademark Results [K-Systems]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 K-SYSTEMS 78432935 2970604 Dead/Cancelled |
KIVEX Biotec Ltd. 2004-06-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.